Active Ingredient: Decitabine
Decitabine is indicated for the treatment of adult patients with newly diagnosed de novo or secondary acute myeloid leukaemia (AML), according to the World Health Organisation (WHO) classification, who are not candidates for standard induction chemotherapy.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Intravenous, 20 milligrams decitabine per square meter of body surface, once daily, 5 doses in total, over the duration of 4 weeks. This step is repeated 4 times.
In a treatment cycle, decitabine is administered at a dose of 20 mg/m² body surface area by intravenous infusion over 1 hour repeated daily for 5 consecutive days (i.e., a total of 5 doses per treatment cycle). The total daily dose must not exceed 20 mg/m² and the total dose per treatment cycle must not exceed 100 mg/m². If a dose is missed, treatment should be resumed as soon as possible. The cycle should be repeated every 4 weeks depending on the patient’s clinical response and observed toxicity. It is recommended that patients be treated for a minimum of 4 cycles; however, a complete or partial remission may take longer than 4 cycles to be obtained. Treatment may be continued as long as the patient shows response, continues to benefit or exhibits stable disease, i.e., in the absence of overt progression.
If after 4 cycles, the patient’s haematological values (e.g., platelet counts or absolute neutrophil count), have not returned to pre-treatment levels or if disease progression occurs (peripheral blast counts are increasing or bone marrow blast counts are worsening), the patient may be considered to be a non-responder and alternative therapeutic options to decitabine should be considered.
Pre-medication for the prevention of nausea and vomiting is not routinely recommended but may be administered if required.
Intravenous infusion over 1 hour.
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